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目的:通过30天给药毒性试验,观察椒枝软胶囊对SD大鼠所产生的各种毒性反应,以评价椒枝软胶囊的安全性。方法:SD大鼠96只,雌雄各半,随机分为4组(空白对照组、椒枝软胶囊高、中、低剂量组),每组各24只。给药组以椒枝软胶囊内容物按4、2、1mL/kg进行大鼠灌胃(相当于3.6、1.8、0.9g内容物/kg),空白对照组给予4mL/kg纯化水,给药30天,于停药次日和停药2周(恢复期)时,各组分别取12只大鼠(雌雄各半)检测血常规、血液生化、脏器系数和脏器组织病理。结果:椒枝软胶囊内容物剂量为4mL/kg、2mL/kg时,对大鼠的肝肾功能及血液系统有一定程度的损伤,但均未造成器官的器质性病变,停药后,损伤情况有所恢复。剂量为1mL/kg时,各方面均未见明显异常。结论:椒枝软胶囊内容物剂量为1mL/kg时,可安全用于临床。
OBJECTIVE: To evaluate the safety of pepper stalk soft capsules by observing the various toxic effects of the pepper stalk soft capsules on SD rats through a 30-day dosing toxicity test. Methods: Ninety-six male Sprague-Dawley rats were randomly divided into 4 groups (blank control group, high-, middle-, and low-dose groups of Jiaozhi soft capsules), 24 in each group. Rats in the drug administration group were given intragastric administration of 4, 2, or 1 mL/kg (corresponding to 3.6, 1.8, and 0.9 g contents/kg), and 4 mL/kg of purified water was administered to the control group. 30 days, on the next day of discontinuation and withdrawal of 2 weeks (recovery period), 12 rats (half male and half female) were taken from each group to test blood routine, blood biochemistry, organ coefficient and organ pathology. Results: When the content of pepper stalk soft capsules was 4 mL/kg and 2 mL/kg, the liver and kidney function and blood system of rats were damaged to a certain extent, but they did not cause organic lesions of the organs. Damage has recovered. At a dose of 1 mL/kg, no significant abnormalities were seen in all aspects. Conclusion: When the content of pepper twig soft capsules is 1mL/kg, it can be safely used in clinical practice.